Anthrax Infection

Plague

Indication for treatment and prophylaxis of plague due to Yersinia pestis

500-750 mg PO q12hr x14 days, OR

400 mg IV q8-12hr x 14 days

Bronchiectasis (Orphan)

Orphan indication sponsor

Aradigm Corporation, 3929 Point Eden Way, Hayward, CA 94545

Noncystic Fibrosis Bronchiectasis (Orphan)

Dry powder for inhalation: Orphan designation for patients with NCFB who suffer from frequent severe acute pulmonary bacterial exacerbations which lead to further inflammation, airway, and lung parenchyma damage

Sponsor

Bayer HealthCare

Dosage Modifications

Renal impairment

CrCl >50 mL/min: Dose adjustment not necessary

CrCl 30-50 mL/min: 250-500 mg PO q12hr

CrCl <30 mL/min: Extended-release, 500 mg PO q24hr

CrCl 5-29 mL/min: 250-500 mg PO q18hr or 200-400 mg IV q18-24hr

Some clinicians suggest decreasing dose but not frequency of administration

Warnings

Black Box Warnings

Serious adverse effects

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and central nervous system (CNS) effects

Discontinue treatment immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions

May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis

Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options

Contraindications

Documented hypersensitivity; concurrent tizanidine administration

Cautions

Use in pregnancy, though generally contraindicated for all quinolones, is allowed for life-threatening situations; limited data from use of ciprofloxacin in pregnancy show no higher rate of birth defects than background

Do not use oral suspension in nasogastric tube; to prepare, add microcapsules to diluent

Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); these reactions can occur within hours to weeks after starting therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones (see Black Box Warnings)

Peripheral neuropathy: sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent

Not first drug of choice in pediatrics (except in anthrax), because of increased incidence of adverse events in comparison with control subjects, including arthropathy; no data exist on dosing for pediatric patients with renal impairment (ie, CrCl <50 mL/min)

Clostridium difficile-associated diarrhea (CDAD) reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated

Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis; postmarketing serious adverse reactions, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in patients with myasthenia gravis; avoid in patients with known history of myasthenia gravis

May also cause CNS events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care

Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; exercise caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)

Cases of status epilepticus have been reported; if seizures occur, discontinue treatment

FDA MedWatch Safety Alert

Issued 12-20-2018

FDA review found fluoroquinolones can cause an increase in occurrence of aortic dissections

Stop treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection

FDA MedWatch Safety Alert

Issued July 10, 2018

The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects

Serious and fatal reactions have reported in patients receiving concurrent administration of ciprofloxacin and theophylline; if concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate

Coadministration of IV ciprofloxacin and other drugs primarily metabolized by CYP1A2 (for example, theophylline, methylxanthines, caffeine, tizanidine, ropinirole, clozapine, olanzapine, and zolpidem) results in increased plasma concentrations of co-administered drug and could lead to clinically significant pharmacodynamic adverse reactions of the co-administered drug

Use with caution in patients with history of seizures taking concurrent therapy that lowers seizure threshold; risk increases rarely when administered concomitantly with NSAIDs

Avoid IV administration in patients who have known QT prolongation, carry risk factors for prolonged QT, or are taking class 1A or class III antiarrhythmic drugs

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Pregnancy & Lactation

Pregnancy category: C

Lactation: Drug enters breast milk; use not recommended (American Academy of Pediatrics Committee states that drug is compatible with nursing)

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

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1

This drug is available at the lowest co-pay. Most
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2

This drug is available at a middle level co-pay. Most
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This drug is available at a higher level co-pay. Most
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This drug is available at a higher level co-pay. Most
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5

This drug is available at a higher level co-pay. Most
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6

This drug is available at a higher level co-pay. Most
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Definition

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